Janssen: Stelara homecare service ran for 28 months without oversight, triggering Clause 2 and public reprimand (AUTH/3436/12/20)

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Key facts

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Case number	AUTH/3436/12/20
Company	Janssen-Cilag Ltd
Product / service	Stelara (ustekinumab) nurse-led homecare service (described by Janssen as a patient support programme)
Therapy areas / indications mentioned	Adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative colitis
Issue period	Lack of oversight January 2018 to May 2020 (service continued for 28 months without company knowledge per Appeal Board)
How it came to light	Vendor requested a new purchase order (24 March 2020); vendor confirmed service had not stopped (29 May 2020)
Key failures admitted	Vendor AE reporting training; product training/SPC updates; documentation review/storage; MHRA AE classification (solicited vs unsolicited)
Adverse event correction	Eleven cases corrected in June 2020 to show as solicited
Patients on service (May 2020)	24
Termination approach	Six-month notice issued 11 September 2020; service continued until 11 March 2021
Complaint received / voluntary admission	01 December 2020
Applicable Code year	2019
Breach clauses	Clause 2; Clause 9.1
No breach clauses	Clause 16.1; Clause 16.3
Sanctions	Undertaking received; Public reprimand; Advertisement; Audit of company’s procedures; Re-audit required
Case completed	15 December 2022

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Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

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Janssen-Cilag made a voluntary admission that it failed to maintain oversight and high standards for a nurse-led Stelara (ustekinumab) homecare service delivered by a third-party provider.
The service began in 2010 for one NHS trust and expanded to up to three trusts; it included home delivery plus nurse-led self-administration training and/or nurse administration support.
In Q1 2018 Janssen decided to terminate the service, incorrectly believing there were no patients and that it no longer delivered value; termination instructions were communicated by email but were unclear and not fully understood.
The service continued from January 2018 to May 2020 without Janssen’s knowledge/oversight; payments continued via an active purchase order managed by an administrator not informed of termination.
Between 2018 and May 2020 Janssen failed to: provide adequate adverse event reporting training to the vendor; maintain up-to-date product training including SPC updates; robustly review/store materials and documents; and correctly characterise MHRA adverse event reports as solicited.
The activity was not recorded as active in Janssen’s Pharmacovigilance System Master File (PSMF), contributing to incorrect MHRA reporting.
Eleven adverse event cases were corrected in June 2020 to be recorded as “solicited”.
Documentation was described as incomplete: Janssen could not identify agreements prior to Q1 2018 describing the service, and there was no documentation in place since January 2018; the vendor could only provide a master services agreement dated July 2015 that did not specifically refer to the Stelara homecare service.
By May 2020 the service was being provided to 24 patients; due to COVID-19 Janssen did not terminate immediately and issued a six-month notice of termination on 11 September 2020, with service continuing until 11 March 2021.
Janssen became aware on 29 May 2020; remediation occurred June–August 2020; voluntary admission was made on 1 December 2020 (over 7 months after discovery), which the Appeal Board considered inexplicably long.
During the case, the Panel also noted Janssen’s position that payments to the homecare provider had not been disclosed on Disclosure UK because Janssen did not consider homecare providers to be healthcare organisations at the time; the Panel highlighted that relevant clarification existed earlier (interim report for AUTH/2883/10/16 published May 2017) and referenced 2019 Code supplementary information on package deals and disclosure.

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Outcome

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Breach found of Clause 9.1 (failure to maintain high standards).
Breach found of Clause 2 (matter of particular censure; patient safety implications; brought discredit upon and reduced confidence in the industry).
No breach found of Clause 16.1.
No breach found of Clause 16.3.
Appeal Board imposed a public reprimand and required an audit of Janssen’s procedures in relation to the Code.
Following the November 2021 audit, the Appeal Board required a re-audit (September 2022) and action plans (by April 2022 and updated ahead of re-audit).
After the September 2022 re-audit and continued improvements, the Appeal Board decided no further action was required (case completed 15 December 2022).

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Key facts

What happened

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